UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of a Test Food for Improvement of Skin Moisturizing Function and Its Safety
Title of the study (Brief title)	Effects of a Test Food for Improvement of Skin Moisturizing Function and Its Safety
Region	Japan

Condition
Condition	N/A(healthy adaults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to examine effects of a test food for improvement of skin moisturizing function and its safety for subjects by 8-week ingestion.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[1]Transepidermal water loss (Screening, Week 0, Week 4, Week 8) [2]Skin moisture content (Screening, Week 0, Week 4, Week 8)
Key secondary outcomes	*Secondary outcomes [1]Visual evaluation (Screening, Week 0, Week 4, Week 8) *Other index [1]Anti-Aging QOL Common Questionnaire (Screening, Week 0, Week 4, Week 8) *Safety evaluation [1]Blood pressure, pulsation (Screening, Week 0, Week 4, Week 8) [2]Weight, body fat percentage, BMI (Screening, Week 0, Week 4, Week 8) [3]Hematologic test (Screening, Week 0, Week 8) [4]Blood biochemical test (Screening, Week 8) [5]Blood test (Screening, Week 0, Week 8) [6]Urine analysis (Screening, Week 0, Week 8) [7]Doctor's questions (Screening, Week 0, Week 4, Week 8) [8]Subject's diary(From the first day of ingestion of a test material to the last day of the test)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Oral ingestion of the test food (8 weeks)
Interventions/Control_2	Oral ingestion of the placebo food A (8 weeks)
Interventions/Control_3	Oral ingestion of the placebo food B (8 weeks)
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	30 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	[1]Japanese females aged 30-59 years. [2]Individuals who are healthy and are not suffered from a chronic malady including skin disease. [3]Individuals who are anxious about skin dryness. [4]Individuals whose written informed consent has been obtained. [5]Individuals who can visit an inspection facility and be inspected in designated days. [6]Individuals judged appropriate for the study by the principal.
Key exclusion criteria	[1]Individuals using medical products. [2]Individuals who use a drug to treat a disease in the past 1 month. [3]Individuals with skin disease, such as atopic dermatitis. [4]Individuals who contract or have a history of serious hepatopathy, kidney damage, heart disease and blood disease. [5]Individuals who contract or have a history of serious endocrine disease. [6]Individuals whose systolic blood pressure is over 160mmHg or diastolic pressure is over 100mmHg. [7]Individuals whose BMI is over 30. [8]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months [9]Individuals with serious anemia. [10]Individuals who are sensitive to a test producer other foods, and medical products. [11]Individuals who are or are possibly, or are lactating. [12]Individuals who are alcoholism or mental disorders. [13]Individuals who have a habit of smoking. [14]Individuals whose bowel habit is irregular. [15]Individuals whose life style will change during the test period. [16]Individuals with probable seasonal allergy, such as pollinosis, during the test period. [17]Individuals who will get sunburned during the test period (including winter sports like skiing and snowboarding). [18]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period. [19] Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. [20] Individuals who use cosmetics having a strong moisturizing effect or improving effect for wrinkle. [21]Individuals who had been conducted an operation on the test spot in the past 6months. [22]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. [23]Individuals who are or whose family is engaged in healthy or functional foods. [24]Individuals judged inappropriate for the study by the principal.
Target sample size	45

Research contact person
Name of lead principal investigator	Takahiro Ono
Organization	Medical Corporation Wakei-kai Medics Hongo Clinic
Division name	Director
Address	2-2-6 Mukogaoka Bunkyo-ku Hongo Tokyo 113-0023, JAPAN
TEL	03-6801-9761
Email	info@tes-h.co.jp

Public contact
Name of contact person	Ryoma Shimizu
Organization	TES Holdings Co., Ltd
Division name	Administrative Department of Clinical Trials
Address	6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL	03-6801-8480
Homepage URL
Email	r.shimizu@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd.
Institute
Department

Funding Source
Organization	LG Household & Health Care Ltd
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization	Korea

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 23 Day
Anticipated trial start date	2017 Year 02 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 02 Month 07 Day
Last modified on	2017 Year 12 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029915